Job summary
The Clinical Trials Monitor is a critical member of the Joint Clinical Research & Development Core Services (Good Clinical Practice and Regulatory Compliance team), sitting within The Royal Marsden's Clinical Research Directorate. The role is responsible for the conduct of monitoring for single and multicentre clinical trials sponsored and/or managed by The Royal Marsden, from initiation to close-out, in compliance with the UK Clinical Trials Regulations. The role develops and maintains close working relationships with the clinical trial management team, and the research delivery teams across participating UK sites.
Main duties of the job
- Undertake monitoring visits in line with clinical trial monitoring plan.
- Prepare and disseminate monitoring reports, ensuring that issues are identified, recorded and resolved.
- Contribute to ensuring that, as far as possible, The Royal Marsden and the ICR remain 'inspection ready'. Take a role in preparing both organisations for statutory MHRA inspections and will work towards positioning us as a leader in quality/compliance in cancer research.
- Act as an expert for The Royal Marsden and the ICR for information and advice regarding clinical trials monitoring, recommending system change and development, and sitting on relevant committees.
About us
The Royal Marsden NHS Foundation Trust is a world-leading cancer centre. Our role is to offer our patients the best cancer care available anywhere in the world, and to continue to make a global contribution to finding better ways of diagnosing and treating cancer. We employ over 4,500 staff in a diverse range of careers including nursing, medical, science, radiography, pharmacy, occupational therapy, finance and administrative services. We have two hospitals - one in Chelsea, London, and one in Sutton, Surrey - as well as a Medical Daycare Unit in Kingston Hospital.
At The Royal Marsden, we deal with cancer every day, so we understand how valuable life is. When people entrust their lives to us, they have the right to demand the very best. That's why the pursuit of excellence lies at the heart of everything we do.
At the heart of the hospital is our dedicated team. We offer a stimulating and dynamic working environment, a wide range of staff benefits, learning and development opportunities and clear career pathways. There are opportunities to work flexibly across a range of areas and specialities and we welcome flexible working requests from point of hire to support employees work life balance. We are looking for employees who aspire to excellence, share our values and can play a crucial role in our on-going achievements.
Job description
Job responsibilities
For further information on this role, please see the attached detailed Job Description and Person Specification:
- Gain knowledge of each clinical trial protocol including procedures and documentation in order to monitor the quality of the trial data, the safety of patient and accuracy of recording of the study in the case report forms and in the medical records
- Together with the clinical trial management team develop and keep updated the risk assessment and risk-based monitoring plans for all assigned clinical trials sponsored and/or managed by The Royal Marsden.
- Work with Trial Management Groups to identify systems for monitoring clinical trial activity at participating sites in accordance with all relevant regulations and SOPs / work instructions.
Job description
Job responsibilities
For further information on this role, please see the attached detailed Job Description and Person Specification:
- Gain knowledge of each clinical trial protocol including procedures and documentation in order to monitor the quality of the trial data, the safety of patient and accuracy of recording of the study in the case report forms and in the medical records
- Together with the clinical trial management team develop and keep updated the risk assessment and risk-based monitoring plans for all assigned clinical trials sponsored and/or managed by The Royal Marsden.
- Work with Trial Management Groups to identify systems for monitoring clinical trial activity at participating sites in accordance with all relevant regulations and SOPs / work instructions.
Person Specification
Education/Qualifications
Essential
- Degree qualification (e.g., BSc) in a relevant subject or equivalent experience.
- Recognised Good Clinical Practice (GCP) certification
- Commitment to continued professional development.
Desirable
- Higher degree qualification (e.g., MSc) in a relevant subject.
Experience
Essential
- Prior experience of working as a clinical trial monitor (either in the academic or commercial sector)
- Experience of working to the UK Clinical Trials Regulations
- Experience of working in an NHS or HEI environment in a clinical research environment.
- Experience of working with staff from a range of backgrounds and different levels of seniority.
Desirable
- Experience of working across organisations.
- Experience of developing a strong culture of customer service.
- Experience of delivering training sessions
Skills / knowledge
Essential
- Proven ability to develop effective working relationships with staff at all levels.
- Detailed knowledge of UK Clinical Trials Regulations and GCP
- Able to summarise and explain complex issues to both technical and non-technical audiences
- Able to work in a proactive manner to identify new risks and issues and flag upwards appropriately
- Ability to deliver poor performance /non-compliance in a constructive manner
- Able to work under pressure, methodical in approach, with effective problem-solving ability.
- Excellent organisational skills
- Proficient IT literacy: evidence of competence with MS Office, particularly Excel, Word, PowerPoint, Teams, and Access.
- Ability to develop new administrative systems to improve efficiency.
- Able to work constructively as an individual; as part of a closeknit team; and as part of a wider research community
Desirable
- Knowledge of systems and processes required to set-up and conduct clinical trials in the UK
- Knowledge of the management and conduct of oncology clinical trials
Person Specification
Education/Qualifications
Essential
- Degree qualification (e.g., BSc) in a relevant subject or equivalent experience.
- Recognised Good Clinical Practice (GCP) certification
- Commitment to continued professional development.
Desirable
- Higher degree qualification (e.g., MSc) in a relevant subject.
Experience
Essential
- Prior experience of working as a clinical trial monitor (either in the academic or commercial sector)
- Experience of working to the UK Clinical Trials Regulations
- Experience of working in an NHS or HEI environment in a clinical research environment.
- Experience of working with staff from a range of backgrounds and different levels of seniority.
Desirable
- Experience of working across organisations.
- Experience of developing a strong culture of customer service.
- Experience of delivering training sessions
Skills / knowledge
Essential
- Proven ability to develop effective working relationships with staff at all levels.
- Detailed knowledge of UK Clinical Trials Regulations and GCP
- Able to summarise and explain complex issues to both technical and non-technical audiences
- Able to work in a proactive manner to identify new risks and issues and flag upwards appropriately
- Ability to deliver poor performance /non-compliance in a constructive manner
- Able to work under pressure, methodical in approach, with effective problem-solving ability.
- Excellent organisational skills
- Proficient IT literacy: evidence of competence with MS Office, particularly Excel, Word, PowerPoint, Teams, and Access.
- Ability to develop new administrative systems to improve efficiency.
- Able to work constructively as an individual; as part of a closeknit team; and as part of a wider research community
Desirable
- Knowledge of systems and processes required to set-up and conduct clinical trials in the UK
- Knowledge of the management and conduct of oncology clinical trials
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
